Sanofi Announces New Phase 3 Results for Amlitelimab in Atopic Dermatitis

Comprehensive Results from SHORE Study

According to the press release, the SHORE study achieved all primary and key secondary endpoints at week 24. This multicenter study included 596 participants aged 12 years and older with moderate to severe atopic dermatitis. Amlitelimab was administered in conjunction with medium potency topical corticosteroids, with or without topical calcineurin inhibitors, in two dosing regimens: every 4 weeks or every 12 weeks. The results were evaluated against placebo using two statistical analysis methods, American and European. The group reports that the drug was well tolerated and the safety profile was consistent with previously reported data. The most common adverse events observed in the study included rhinopharyngitis at 9.5%, upper respiratory tract infection at 7.9%, and atopic dermatitis at 2.7%, compared to 12.5%, 4.4%, and 5.6% respectively in the placebo group.

Mixed Results in COAST 2 Study

The COAST 2 study, which evaluated amlitelimab as a monotherapy in 547 participants, presented mixed results according to geographical areas, the company indicates. For the United States and American reference countries, the primary endpoint regarding the proportion of patients achieving a vIGA-AD score of 0 or 1 with at least a 2-point reduction from the baseline score was met at week 24. However, the key secondary endpoint regarding the vIGA-AD score of 0 or 1 with barely perceptible erythema did not reach statistical significance. For the European Union and EU reference countries, amlitelimab did not achieve statistical significance for the co-primary endpoints, according to the press release. The most common adverse events in this study included rhinopharyngitis at 5.9%, upper respiratory tract infection at 4.8%, and atopic dermatitis at 5.3%, compared to 7.4%, 4.0%, and 2.7% respectively in the placebo group.

Preliminary Analysis of Ongoing Phase 2 ATLANTIS Study

A preliminary analysis of the ongoing phase 2 ATLANTIS study, involving 591 patients aged 12 years and older, showed that amlitelimab administered every 4 weeks progressively improved the disappearance of skin lesions and the severity of the disease beyond week 24 up to week 52, according to the group. In this analysis, the drug was well tolerated up to week 52. The most common adverse events included rhinopharyngitis at 19.1%, headaches at 10.3%, and influenza at 9.1%. A case of cutaneous Kaposi's sarcoma was reported in a patient with known risk factors, who discontinued treatment and is in recovery phase, the press release specifies. Two additional phase 3 studies, AQUA and ESTUARY, are expected to publish their results in the second half of 2026. According to Sanofi, global regulatory submissions are planned for the second half of 2026. Amlitelimab selectively targets the OX40 ligand and blocks OX40L signaling during the initial inflammatory phase without destroying T cells, the company explains.